Method and apparatus for repairing the mid-foot region via an intramedullary nail

ABSTRACT

A device, method, and system for treatment or fixation of a fractured, damaged, or deteriorating bone or bones in a mid-foot region. The device comprising an implant with both proximal and distal fastener holes, along with fastener slots in a central elongated body, for securing the implant to the appropriate osseous cortical structures of the foot. The method for treatment or fixation of fractured, damaged, or deteriorating bones in the medial column of the foot with use of a device such as an intramedullary nail that attaches to either the talus or first metatarsal bones to secure the medial cuneiform and navicular bones in place.

CROSS-REFERENCE OF RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/833,118 filed Dec. 6, 2017, now U.S. Pat. No. 10,238,437,which is a continuation of U.S. patent application Ser. No. 13/593,987filed Aug. 24, 2012, now U.S. Pat. No. 9,867,642, which is acontinuation of U.S. patent application Ser. No. 10/525,544 filed Jan.28, 2005, published as U.S. Patent Application Publication No.2006/0206044 A1 and now abandoned, which is a national phase entry under35 U.S.C. § 371 of International Application No. PCT/US2003/024185 filedAug. 1, 2003, published as International Publication No. WO 2004/014243A1, which claims priority from U.S. Provisional Patent Application No.60/402,380 filed Aug. 10, 2002, all of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION Field of the Invention

The field of the present invention relates to a method and apparatus forrepairing damaged, deteriorating, or fractured bones in the mid-footregion. More particularly, the present invention relates to both amethod and device for treating the bones in the medial column of a humanfoot that are effected by Diabetic Charcot mid-foot collapse, LisFrancinjuries, and the like.

Description of Related Art

The utilization of implants, such as intramedullary nails, rods, andscrews is well known in the art, specifically in the treatment of longor large bone fractures. Implants are those devices which may beinserted into any foreign body, with intramedullary nails being the mostcommon type of implant. Intramedullary nails have been limited in theirapplication to long or large bones and such use has been widely knownfor long or large bones of the upper extremities (humerus, radius, ulna)and lower extremities (femur, tibia, fibula). Use of intramedullarynails allows physicians to secure fractured bones, maintain a desiredlength, and prohibit rotary motion while the bone heals and has time torehabilitate. Intramedullary nails are also used for the fusion ofbones.

Intramedullary nails are adapted for insertion into the medullary canalof a bone or bones, which may be reamed or left unreamed. Reaming isachieved by drilling out the medullary canal of the fractured ordeteriorating bone, where the nail is inserted to stabilize and positionthe bone for healing. A cannulated reamer diameter generally runs insize from 7 mm and 18 mm, at increments of 0.5 mm A medullary canal isgenerally reamed at 0.5 mm larger than the diameter of the nail to beinserted, so the bone is not damaged when the nail is inserted. Suchreamers are well known by those with skill in the art.

Much of the prior art implant and intramedullary nail systems compriseintramedullary nails having fastener holes at both the proximal anddistal ends for the insertion of fasteners, or locking screws. Fastenersinclude all attaching means by which an implant may be attached to bone.Such fasteners are inserted through a fastener hole or slot, alsodescribed as transfixation holes and screw holes. The use of lockingscrews is optional depending upon the severity of the bone damage. Anintramedullary nail implanted with at least one fastener or lockingscrew both proximally and distally completely locks the nail in place(also known as static locking). Static locking neutralizes rotationalstresses while preventing shortening of the limb. An intramedullary nailimplanted with only one locking screw either proximally and distally,partially locks the nail (also known as dynamic locking). Dynamiclocking neutralizes rotational stresses on one side of the fracture sitewhile permitting axial loading. To surgically promote fusion of bonesegments together, some means of static locking is required. Such holesand screws may also be adapted for the central portion of the nail orimplant.

Several nails exist with fasteners or locking screws that are muchlonger in shape, described as lag screws, jigs, or nail heads, whichfurther prevent the rotation of separated bones. Other nails havespacers to absorb stress associated with repetitive, natural impact. Allsuch devices are focused on securing bone fragments during the processof fracture healing. Other methods for attaching the nail to the boneincluding the use of longitudinal pins, or the use of cement injectedthrough a cannula in a nail to secure one end to the nail.

Various types of implants and intramedullary nails exist in the priorart, each composed of different materials and having different shapeswith various degrees of functionality. Many nails are formed from eithera slid rod metal or a more flexible sheet metal. Several nails have beenproposed which form a rod material containing a central longitudinalbore disposed throughout (cannulated). Many nails have a number oflongitudinal grooves cut along the rod (known as fluting), which allowfor more rapid revascularization within the bone. Accordingly, nailsmade of various material and those having a differing array of shapesalready exist and may be easily manufactured. A study of the geometricalproperties of different nails is discussed in the article “GeometricalProperties and Torsional Fatigue Life of a Tibial InterlockingIntramedullary Nail Segment” Journal of Orthapedic Trauma, Vol. 12, No.1, pp 8-15, and is incorporated herein. Also, different tibial nailswere compared in the article “Biomechanical Study of Nine DifferentTibia Locking Nails” Journal of Orthapedic Trauma, Vol. 10, No. 1, pp37-44, which is also incorporated herein.

Recently, implants and intramedullary nails are being fabricated usingbioactive, biocompatible, and bioabsorbable material. Such nails aremade from bioabsorbable polymers, copolymers, or polymer alloys that areself-reinforced containing ceramic particles or some type ofreinforcement fibers. These implants and nails, as well as others, canalso be made to be porous. The knowledge exists today to create humanreplica bones, grown in animals utilizing human gene technology, forultimate use in humans, and such material may be a viable supplement forstandard intramedullary nails of today. Such techniques should also beconsidered as an appropriate part of the present invention.

While there is much in the art regarding implants and intramedullarynails, there was no prior art found dealing directly with implants orintramedullary nails for the mid-foot region, or medial column of ahuman foot. Such a nail may likely have any or all of the similarproperties, features, and characteristics of the above mentioned nails,but would have to be much smaller in length and thickness (for axialsupport) to accommodate the smaller bones of the mid-foot region. Theprior art referring to intramedullary nails, for the most part, refersto nails which are used in much larger bones. Such art includes:

WO 00/72767 A1. The application describes an intramedullary nail forinsertion within an intramedullary canal of a long bone and fixing afracture in the long bone. The nail comprises an elongate member withlongitudinal axis, proximal and distal end, both of which have fastenerreceiving areas of at least one hole.

U.S. Pat. No. 6,406,477. The patent describes an intramedullary nailwith a lag screw for connecting a bone portion separated from the femur,by fracture, to the main portion of the bone where such nail is capableof extending through both portions where a lag screw secures the nail.

WO 02/34107 A2. The Application describes an internal fixation devicewhich utilizes a shaft within a sleeve wherein the shaft is movablewithin the sleeve along aligned slots.

U.S. Pat. No. 6,270,499 B1. The patent describes an intramedullary nailwhere the proximal end has at least one bore which extends transverselyto the central axis of the nail for receiving at a stable angle a bonefastener.

U.S. Pat. No. 6,406,498 B1. The patent describes a device, such as anintramedullary nail or the like, which is fabricated using bioactive,biocompatible, and/or bioabsorbable material.

U.S. Patent Application No. US 2002/0029041 A1. The applicationdescribing an intramedullary nail formed with opposing dynamizationwindows and spacers of nonmetal material positioned within the windowsto absorb stress transmitted through a fracture site.

U.S. Pat. No. 6,120,504. The patent describes an intramedullary nailwith a longitudinal centerline extending between a proximal and distalend. The invention is directed to be interchangeably used in either aright or left limb, and to thus reduce the number of nail that must beinventoried at hospitals and other places utilizing intramedullarynails.

U.S. Pat. No. 4,705,027. The patent describes an intramedullary nailhaving a slot at the tip of the nail for engaging within the slot, abolt previously inserted into the bone.

U.S. Pat. No. 5,658,287. The patent describes a locked intramedullarynail suitable for treating fractures of the femur.

U.S. Pat. No. 5,034,013. The patent describes an intramedullary nailhaving a tubular elongated body with grooves along the elongated body toallow for improved revascularization about the nail.

U.S. Pat. No. 5,766,174. The patent describes an intramedullary nailwith an arcuate terminus tip, transverse holes for receiving fixationscrews, and suture holes for the attachment of tissue.

U.S. Pat. No. 5,336,225. The patent describes device for reducingfractures, comprising a threaded screw.

U.S. Pat. No. 6,123,708. The patent describes a nail for axial insertioninto a bone for support comprising a central bore through the nail bodyand a plurality of transverse holes throughout.

U.S. Pat. No. 5,814,047. The patent describes an intramedullary nailfixation apparatus having a plurality of equiangularly spaced piercingpoints.

U.S. Pat. No. 5,855,579. The patent describes a modular intramedullarynail having an open ended longitudinal bore, with connectable ends forelongating the nail.

EP 1095626 A1. The patent describes a radial intramedullary nail.

U.S. Pat. No. 5,620,445. The patent describes a modular intramedullarynail with proximate, distal, and central components.

There is no known prior art relative to the use of intramedullary nailsin the treatment of mid-foot bones or more specifically, treating thebones of the medial column. Most of the prior art describing the use ofintramedullary nails is limited to methods for repairing large bonesincluding, but not limited to the humerus, radius, ulna, femur, tibia,and fibula. Such art includes:

U.S. Pat. No. 6,019,761. The patent describes an intramedullary nail forimplanting within a patient's long bone, and a method of use.

U.S. Pat. No. 5,201,735. The patent describes an apparatus such as abone implant and method for implanting a bone implant or intramedullaryrod for fixing a fracture of a bone.

U.S. Pat. No. 5,935,127. The patent describes a method for treating afracture in a long bone by utilizing either a plate or intramedullarynail that spans the length of the bone.

U.S. Pat. No. 5,919,193. The patent describes a method for surgicallycorrecting malformations in digits of a finger or toe by way of a onepiece bone screw.

U.S. Pat. No. 4,976,712. The patent describes a method and apparatus fortreating fractured bones by way of a bone screw.

The prior art relative to current treatments of mid-foot deformities,particularly those analogous to this type of treatment, are limited to:

“Charcot Ankle Fusion with a Retrograde Locked Intramedullary Nail” Foot& Ankle International, Vol. 18, No. 11, November 1997. This articlefocuses primarily on ankle fusion with a locked intramedullary nail, butspecifies mid-foot deformity treatment to be limited to patienteducation, local foot-care, accommodative shoe gear, custom footorthoses, and surgical correction.

Additional articles of significance include; “Surgical Reconstruction ofthe Diabetic Foot: A salvage approach for mid-foot collapse” Foot AnkleInt., Early, J. S. and Hansen, S. T., 17: 325-330, 1996 and “Arthrodesisas an Early Alternative to Nonoperative Management of Charcot Arthopathyof the Diabetic Foot”, The Journal of Bone and Joint Surgery, Inc., S.R. Simon Et A I., Vol. 82-A, No. 7, July 2000.

“The Lateral Column Lengthening and Medial Column StabilizationProcedures” Clinical Orthopedics and Related Research, T. D. Chi Et al.,No. 303, August 1999. Is an article that is the closest related study ofsurgical repair procedures to the present invention; however, itdescribes the use of multiple screws to secure the bones within themid-foot which produced severely limited results.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to a device and method for treatingand fixation of deteriorating, damaged, or fractured bones in themid-foot region (navicular, medial cuneiform, intermediate cuneiform,lateral cuneiform and cuboid bones). More specifically, the presentinvention relates to the treatment and fixation of certain bones in themedial column (specifically, the medial cuneiform and navicular bones)of a human foot. Such bones are not considered long or large in thetraditional sense as are those specified above. An apparatus, such as animplant, or more specifically an intramedullary nail, is insertedthrough and attached to both the first metatarsal and talus bones tosecure the medial cuneiform and navicular bones in place. This procedurealso is expected stabilize all the bones in the mid-foot region. Afterappropriate reduction and compression, such a method and device wouldultimately allow for fusion of the bones. In accordance with the presentinvention, one device used to achieve the above described method is acannulated intramedullary nail that is round in cross-section, having anelongated body with a proximal head portion, intermediate portion, anddistal tapered end portion. The proximal head portion has one or moretransverse holes, ideally three, with an intermediate portion having oneor more transverse slots, ideally two, and a distal portion having oneof more transverse holes, ideally two. Such transverse fastener holes orslots are used for insertion of fasteners (including interlockingcortical screws or transfixation screws), which ideally may be attachedto the first metatarsal and talus bones to secure the nail in place.Slots are adapted for the central portion of the nail for the insertionof fasteners into either the navicular or medial cuneiform, dependingupon the condition of either of the two bones.

One object of the present invention is to provide an implant orintramedullary nail for the treatment and fixation of those bones withinthe mid-foot that are subject to damage, deterioration, or fracture thatmay result from diabetes related diseases, including but not limited to,Charcot foot. More than 16 million Americans have diabetes, of whichapproximately 54,000 patients underwent lower extremity amputations in1990. The five-year mortality rate for diabetics has been reported ashigh as 70%. Approximately 800,000 Americans develop diabetes annually.The cost of caring for diabetes now exceeds S137 billion per year, orapproximately 30% of the annual Medicare budget. Diabetic neuropathyultimately results in deterioration of the bones in the foot. Suchdeterioration of those bones in the mid-foot region leads to thecollapse of the foot, fracture of those bones, or both. The prevalenceof Diabetic Charcot joints has been reported to be from 0.08% to 7.5%.The average age of onset is approximately 57 years with the majority ofpatients in their sixth and seventh decades. The average duration ofdiabetes with a diagnosis of Charcot arthropathy is 15 years, with 80%of the patents being diabetic for more than 10 years. Bilateral Charcotarthropathy has been reported between 5.9% to 39.9%. Incidence ofDiabetic Charcot arthropathy appears equally among men and women.

Diabetic foot treatment to date has been limited to amputation, specialcasts or shoes which alleviate the deformity, and surgical interventionto strengthen the foot. An article describing an overview of diabeticfoot problems is “Diabetic Neuropathic Osteoarthropathy: The CharcotFoot” Chapter 16 of The High Risk Foot in Diabetes Mellitus, edited byR. G. Frykberg, © Churchhill Livingstone Inc., 1991, and is incorporatedherein. Amputation of the opposite extremity is frequently indicatedwithin one to five years of the primary amputation. Surgicalintervention has been restricted to the use of screws and plates sincemost bones in the foot are quite small. Methods used to repair largerbones with devices such as intramedullary nails have not been utilizedin this area until now.

The medial column of the foot is comprised of six osseous components(distal phalanx, proximal phalanx, first metatarsal, medial cuneiform,navicular, and talus). The longitudinal arch of the foot is maintainedby these bone segments and their supporting ligaments, tendons, andsurrounding musculature. Additional support comes from the transversearch and the interlocking of the osseous components. The medial columnof the foot is the most commonly affected in the diabetic bysympathectomy-induced hyperemia associated with repetitive minor traumaresulting in mid-foot dislocations and/or fractures known as DiabeticCharcot deformities.

Treatment of foot and ankle Charcot deformities currently consists ofnonsurgical (non-contact casting, orthotic bracing, and shoe gear) andsurgical stabilization (k-wires, screw/plate fixation, and externalfixators). Recently, implant and intramedullary nail fixation has beenutilized to stabilize the ankle/subtalar joint complex. Presenttreatment for medical column/mid-foot deformities requires extensivesurgical exposure with appropriate internal screw/plate fixationdevices. One advantage of using an implant or intramedullary nail fortreatment and fixation of these bones, is the limited surgical exposurethat is required with only several small incisions, as opposed to themore invasive exposure resulting from opening the entire foot forinsertion of several internal screws and plate devices. Also, thesuccesses of screw and plate fixation is minimal at best.

Although prior art nails have found varying degrees of success in thetreatment of long bone fractures and hind-foot arthrodesis, thereremains a need in the field for an intramedullary nail specific forfixation of the medial column of the foot. This device willsubstantially reduce, if not eliminate many of the present complicationsencountered with Diabetic Charcot foot reconstruction. Such a devicewould provide fixation and stabilization of the Diabetic Charcot footpreventing future mid-foot collapse and ultimate limb loss. Anintramedullary medial column nail and method of utilization wouldprovide stabilization to the medial column of the foot, eliminatingexcessive operating time, anesthesia exposure, implant failure, longhospital stays, and reduce overall medical cost leading to earlyrehabilitation and ultimately limb salvage.

The present invention specifically relates to the fusion, and eventualrejuvenation of the bones in the mid-foot region which deterioratebecause of diabetic neuropathy. The method comprises insertion of animplant or intramedullary nail through the medial cuneiform andnavicular bones, which are most susceptible to deterioration, andsecuring the nail with locking screws to the stable first metatarsal andtalus bones. This is one method for securing, fusing, and repairing themedial cuneiform and navicular bones and represents one embodiment ofthe present invention.

The present invention utilizes an intramedullary medial column nailfixation apparatus ideally being cylindrical and cannulated, and madefrom either titanium, a bioabsorbable material, human or animal bone, orequivalent. The nail ideally would have a number of proximal and distalfastener holes (transfixation or interlocking holes) for securing the IMmedial column nail to the appropriate osseous cortical structures of thefoot. An important feature of the present invention of the IM nail isits ability to function as an internal load-sharing device along themedial column of the foot. The nail acts as an internal splintage whilethe bones are mending, and is used to bring into alignmentmicrofractures that may exist. The proximal portion of the nail may havea tapered tip to aid in insertion, and at least one fastener hole(ideally two) for the insertion of fasteners to fixate the neck of thetalus to the implant or nail. The intermediate portion ideally has twoslots to accommodate for any bone loss of the navicular and medialcuneiform, and to allow for the possible insertion of a fastener if thebones are healthy enough. The distal portion has at least one fastenerhole (ideally three) for the insertion of fasteners to fixate the nailto the first metatarsal.

The present invention may also make use of a specialized thin walledtubular chisel system for removal of first metatarsal head articularcartilage for nail insertion 30. This maintains the integrity of thefirst metatarsal head by removing only an appropriate sized plug of boneaccording to the diameter of nail being used. The plug of articularcartilage and underlying bone can then be replaced and fixated afterinsertion of the nail. Such a chisel system may be similar to one thathas been used in osteochonral autograph transfer.

In addition, another embodiment of the present invention calls for theuse of a compression system that incorporates a depth gauge device whichmay be used to determine the amount of compression achieved. This devicewould eliminate the need for guessing or “feeling” the correct amount ofcompression required. A depth gauge would exist either on the implant orjig apparatus with a ruler type measuring means for gauging the amountof travel in the nail back up the intramedullary canal towards thephalanges. Compression could then be determined to a specified length oftravel of the nail back up the canal during compression.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top down skeletal outline of a right human foot with animplant located within.

FIG. 2 is a side skeletal outline of a left human foot with an implantlocated within.

FIG. 3 is an x-ray picture taken following an experimental procedure toinsert an implant into a patient's foot.

DETAILED DESCRIPTION

The following description will explain the embodiments of the invention,beginning with a device used for treating deteriorating or damaged bonesin the medial column of a human foot, and concluding with the method fortreating deteriorating or damaged bones in the medial column of a humanfoot. Both the first and second figures are skeletal outlines of a humanfoot, depicting the device therein and the resulting orientation of thebones by using the method specified below.

FIG. 1 is a top down view of a right human foot, depicting the bonestherein and an implant or intramedullary nail 10 running through themid-foot region. The implant or intramedullary nail 10 runs through themedullary canal of first metatarsal 7, medial cuneiform 3, navicular 2,and talus bone 1. The talus bone 1 makes up the lower part 20 of theankle joint where the proximal end 11 of the implant or intramedullarynail 10 is attached with at least one fastener (or locking screw, withtwo depicted in FIGS. 1, 14 & 15). Next to the talus bone, opposite therest of the ankle bones, are the tarsal bones which include thenavicular 2, medial cuneiform 3, intermediate cuneiform 4, lateralcuneiform 5, and cuboid bones 6. The medial cuneiform 3 and navicular 2bones are those most affected by the Diabetic Charcot foot disorder,which causes deterioration and possible collapse as a result of themechanics behind the foot and the amount of weight they are responsiblefor. These are the bones that the present invention focuses on fixationand stabilizing for rejuvenation, and insertion of an implant orintramedullary nail 10 through them as an embodiment of the invention.If either of the two bones are stable enough to support a locking screw,the nail is designed to have holes for that purpose, a first fastenerhole 16 for the navicular bone 2 and a second fastener hole 17 for themedial cuneiform 3. These two fastener holes transverse the axialcentral axis (central elongated body) 13 of the nail. Finally, the firstmetatarsal 7 is the bone that makes up the big toe in the human foot,where the distal end 12 of the intramedullary nail 10 is attached by wayof at least one fastener (or locking screw, with three depicted in FIGS.1, 20, 19, and 18).

FIG. 2 is a side view of a left human foot, depicting the bones thereinand an implant or intramedullary nail 10 running through the mid-footregion. Again, the implant or intramedullary nail 10 runs through themedullary canal of first metatarsal 7, medial cuneiform 3, navicular 2,and talus bone 1. This figure shows the phalanges bones (8 & 9) whichare joined to the first metatarsal 7, at which the joint must bedislocated downward (as will be discussed below) prior to insertion ofthe intramedullary nail 10. Proximal end 11 of nail 10 defines a chamfersuch that the implant may be inserted up into the talus bone 1 farenough so that at least one of proximal fastener holes (14 & 15depicted) are within the bone.

The nail 10, being one embodiment of the present invention, must besized (length and diameter) so that it extends far enough into the talusbone 1 to clear at least one fastener hole, and include fastener holesfor the proper attachment of fasteners (locking screws) in the remainingbones, at least one fastener hole (with three depicted in the FIGS. 20,19, & 18) for attaching and locking the nail to the first metatarsal 7,and optionally, a first fastener hole 16 for the navicular bone 2 and asecond fastener hole 17 for the medial cuneiform 3.

A second embodiment of the present invention is the method by which adevice (such as an intramedullary nail as depicted in FIGS. 1 & 2) maybe used and inserted into and through the mid-foot region to supportdamaged or deteriorating bones therein. The first step would consist ofthe taking of x-ray pictures of the unhealthy foot to determine theextent of the injury, and the size (length and diameter) of the deviceor implant (herein, intramedullary nail 10, as depicted in FIGS. 1 & 2)needed for insertion. Second, dislocation of the phalanges 8 which areattached to the first metatarsal must be done to expose the head of thefirst metatarsal. Third, an arthrotomy of the first metatarsal 7 isdone. Fourth, as an optional embodiment of the present invention, atubular chisel system may be used to remove a plug of bone and cartilagefrom the underlying head of the first metatarsal (which can then bere-plugged after insertion of the nail to more rapidly promote healingand not leave a gap in the head of the bone as one skilled in the artwould recognize). Fifth, closed reduction is performed on the bones inthe mid-foot region which may be sagging or close to collapse as aresult of deterioration or fracture. Sixth, a guide-wire is insertedthrough the medullary canal of first metatarsal 7, medial cuneiform 3,navicular 2, all the way into the talus 1 with use of fluoroscopy tomaintain correct alignment of the foot. The first guide-wire may have aball tip on the end to make sure the flexible reamer may be easilyremoved if it breaks. The seventh step consists of reaming over theguide-wire with the ball tip all the way into the talus 1. The reamingis done under fluoroscopy so that the correct depth into the talus 1 maybe achieved. Reaming should be done at 0.5 mm diameter larger than thenail to be inserted. The eighth step consists of placing the appropriatesized nail into a jig apparatus with outrigger, and then inserting thenail into the first metatarsal 7, by running over a smooth guide-wire.The nail is centered into the medullary canal beginning with the firstmetatarsal 7, and then through the medial cuneiform 3, navicular 2, andtalus 1 bones respectively. Ninth, at least one fastener (or lockingscrew, with two depicted in FIGS. 1, 14 & 15) is placed percutaneouslyinto the proximal fastener hole of the nail, and into the talus bone.This procedure only requires a small stab incision, that which one“skilled in the art” would appreciate. The tenth step, is an optionalstep of compression that may be achieved with a nail of the type havinga trocar and sleeve mechanism known in the art, or the like. A furtherembodiment of the present invention could include a depth gauge devicewhich may be used to determine the amount of compression achieved, thatwhich is determined by the width of the bone. This device wouldeliminate the need for guessing the correct amount of compressionrequired, since the amount of compression could then be determined to aspecific length of travel of the nail back up the canal. An in-linecompression sleeve may be one means used to afford compression upon thebones in the mid-foot region. After adequate compression is achieved(that which would be known by those skilled in the art), the eleventhstep involves insertion of at least one fastener (or locking screw, withthree depicted in FIGS. 1, 20, 19, & 18) into the distal fastenerhole(s) and also into the first metatarsal. The same process ofpercutaneously inserting the fasteners as noted above for the proximalend can be replicated here. Fasteners may be optionally included inslots 16 for the navicular bone 2 and 17 for the medial cuneiform 3,depending upon the condition of either of these two bones. The twelfthstep consists of removing the jig and replacing the plug of bonepreviously removed (if such step was utilized). The joint is thenreduced (relocated) and the joint capsule is repaired and the sites areall sutured.

FIG. 3 is an x-ray picture taken following an experimental procedure toinsert an implant into a patient's foot with two fasteners at both theproximal and distal ends. The procedure, performed in March of 2000, isbeing followed-up to determine the effectiveness of the newly adaptedtreatment. This is the only procedure to date ever performed of itskind. Such a procedure is an embodiment of the present invention.

The implant was a small intramedullary (Smith & Nephew) nail intendedfor insertion in a longer bone. The fasteners were locking screwsinserted into the transfixation holes and also into the talus and firstmetatarsal bones. Such a device is an embodiment of the presentinvention.

The invention claimed is:
 1. A surgical method comprising the steps of:inserting a first implant into a navicular bone of a foot; and securingthe first implant to the foot with a first threaded connection to atalus bone of the foot.
 2. The surgical method of claim 1, furthercomprising a step of securing a second implant to the foot, the firstimplant being attached to the second implant.
 3. The surgical method ofclaim 1, further comprising a step of securing the first implant to thefoot with a second threaded connection to a bone of the foot.
 4. Thesurgical method of claim 3, wherein the first implant is secured to afirst metatarsal of the foot.
 5. The surgical method of claim 1, furthercomprising a step of inserting a first fastener into a first holethrough the first implant, wherein the first fastener provides the firstthreaded connection.
 6. The surgical method of claim 5, furthercomprising the steps of: inserting a second fastener into a second holethrough the first implant; and securing the first implant to the footwith a second threaded connection between the second fastener and a boneof the foot.
 7. The surgical method of claim 5, wherein the firstimplant is secured with the second threaded connection to a bone of thefoot different from the talus bone of the foot.
 8. The surgical methodof claim 1, wherein the first implant is an intramedullary nail.
 9. Asurgical method comprising the steps of: inserting a first fastenerentirely through an intramedullary nail extending within a mid-footregion of a foot and into a first bone in the mid-foot region of thefoot to secure the intramedullary nail with a first threaded connectionto the first bone; and securing the intramedullary nail with a secondthreaded connection to a second bone of the foot different from thefirst bone.
 10. The surgical method of claim 9, further comprising astep of inserting the intramedullary nail into a plurality of bones ofthe foot.
 11. The surgical method of claim 10, wherein the plurality ofthe bones of the foot includes the first and the second bones of thefoot.
 12. The surgical method of claim 9, wherein the first bone is afirst metatarsal of the foot.
 13. The surgical method of claim 9,wherein the second bone is a medial cuneiform of the foot, a navicularbone of the foot, or a talus bone of the foot.
 14. The surgical methodof claim 9, further comprising the steps of: aligning a first holeextending through the intramedullary nail with a first metatarsal of thefoot, a medial cuneiform of the foot, a navicular bone of the foot, or atalus bone of the foot; and aligning a second hole extending through theintramedullary nail with the first metatarsal of the foot, the medialcuneiform of the foot, the navicular bone of the foot, or the talus boneof the foot.
 15. The surgical method of claim 14, further comprising thesteps of: inserting the first fastener through the first hole; andinserting a second fastener through the second hole.
 16. The surgicalmethod of claim 9, further comprising a step of inserting an implantinto at least one bone of the foot and spaced from the intramedullarynail.
 17. A surgical method comprising the steps of: disposing anentirety of an intramedullary nail in a first plurality of bones of afoot; and disposing an entirety of a rod in a second plurality of bonesof the foot, the rod being spaced from the intramedullary nail.
 18. Asurgical method comprising the steps of: disposing an entirety of afirst implant in a first plurality of bones of a foot; disposing anentirety of a second implant in a second plurality of bones of the foot,the second implant being spaced from the first implant; and securing thefirst implant to the foot with a first threaded connection by a fastenerdistinct from the first implant and the second implant.
 19. The surgicalmethod of claim 18, wherein the first implant is an intramedullary nail.20. The surgical method of claim 18, further comprising a step ofsecuring the first implant to the foot with a second threadedconnection.